The invention deals with a hermetically sealed container, and aims primarily at the medical use of such container.
A first type of container currently in use includes a stopper, a membrane covering the stopper, and a cap crimped around the neck. The cap is precut so that a central portion may be removed uncovering a corresponding area of the membrane to which it gives access. The part of the cap that is left isolates hermetically the interior of the container with respect to the surrounding environment through the tight compression of the membrane over the stopper and through both against the neck. The stopper has two holes bored vertically in it. One is intended for the passage of the fluids to be withdrawn from the container, and the other is for the entry of the air that must replace those fluids.
Depending on the formulation, the contents may be placed inside the container either in an industrial plant for mass production, within a health care facility by completely extemporaneously compounding custom formulas, or by partial compounding by adding materials to the contents placed inside the container at the plant.
In the medical utilization of such containers in an ordinary environment, it is of critical importance in order to avoid detrimental effects on a patient's health such as septicemias and ischemias to avoid administering to the patients contents that have been contaminated by undesirable biologically active or inactive particles. Ischemias are caused by particles clogging smaller blood vessels, are particularly critical in certain organs and have been suspected by some to have some relation to certain forms of cancers.
At the industrial level, exacting procedures make it possible to end up with hermetically sealed containers free of any undesirable particle. This result is achieved thanks to sophisticated and expensive equipment handled by handpicked highly qualified professionals.
If a fluid is to be introduced into the container in a hospital setup, the operator pierces through the membrane with a hollow needle within a visual indicator or at the vertical of one of the holes mentioned, if existing in the stopper, and injects the fluid inside. This procedure involves the risk of contaminating the interior with undesired particles because the needle passing from the surrounding environment into the container may carry inside particles existing outside. Furthermore, the needle may also cut part of the membrane, the stopper or both, or it may allow the air outside to be sucked in because of the internal vacuum. Any germs reaching the fluids may proliferate even in the presence of preservatives.
For the administration of the container's contents to the patient, the membrane is broached at one of the two holes for the extraction of the fluids and at the other hole to permit the surrounding air to replace the departing fluid (replacement air). Some devices require one piercing only because they carry two canals on one stem; one canal allowing the fluids out and the other allowing the replacement air in.
A second type of container has only a single and smaller stopper without any hole bored in it nor any membrane on top of it. It is tightly compressed and kept in place by one or two crimped caps that are precut so that their central portion may be removed uncovering an equivalent area of the stopper. This stopper must again be pierced through its thickness for the extraction of its contents, either in a continuous manner (for slow perfusion), or repetitively in the course of time (vitamins, hormones, anibiotics), and to let in the replacement air. The larger containers usually are deprived of any internal gas when they leave the plant so that compounding is facilitated extemporaneously. However, air must be aspirated at the end of the compounding phase to eliminate the pressure differential before dispensing.
The containers of the second type are plagued by the same risks of contamination. With these two types of containers now in general use, any tampering with the original seals that is not very carefully monitored by a professional may cause at least a deformation of the elastic membranes letting in the surrounding air that may carry contaminants and suppress the pressure differential so helpful to compounding. As a matter of fact, this vacuum is necessary because it permits the insertion of additives without having to withdraw an equal volume of gas from inside. Furthermore, the presence of a vacuum at compounding or dispensing time after a long storage period is a very important safety check of air seepage and contamination.
To remedy these difficulties of extemporaneous utilization, one proposed measure is to include a rudimentary filter on the air inlet within the two-canal device mentioned earlier. However, this filter, which is close to the end to be inserted in the stopper, is regularly contaminated by the operator. It is common practice at the end of compounding to microfilter the full contents (post compounding microfiltration), particularly warranted in the case of large volume of fluids for parenteral fluid thereapy, or total parenteral nutrition, from which preservatives are barred.
In-line microfiltration is a common practice during dispensing of the fluids to the patient. These important microfiltrations are slow, tedious and leakprone, and they necessitate highly paid professionals using very expensive equipment.
The invention aims primarily at correcting these perplexing inconveniences and difficulties by providing a compact portable container with integrated shielding and operating features so that operations are rigidly limited and foolproof, resulting in continuously shielding the contents during the diverse manipulations.
Another object of the invention is to suppress the need for recreating very special environments at the time of utilization. The plant quality cannot be achieved without huge investments in equipment and professionals permanently on the alert.